Levothyroxine Sodium
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2002
Approved
Approval ID
e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2023
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1817
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (13)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 175 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1803
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (10)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 50 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1809
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (12)
LEVOTHYROXINE SODIUMActive
Quantity: 100 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1823
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (11)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 137 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1819
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (11)
LEVOTHYROXINE SODIUMActive
Quantity: 200 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1821
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (13)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 300 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1811
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (12)
LEVOTHYROXINE SODIUMActive
Quantity: 112 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1805
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (12)
LEVOTHYROXINE SODIUMActive
Quantity: 75 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1800
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (11)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 25 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-1807
Application NumberANDA076187
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (13)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 88 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT